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EC number: 692-061-0 | CAS number: 1207435-39-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Only a 7-day dose range-finding study (BIOTOX-21) is available for repeated dose toxicity of Fast Pyrolysis Bio-oil. Testing is not proposed based on REACH annex VIII section 8.6.1 column 2: The short-term toxicity study (28 days) does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI Section 3: Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. Moreover, according to ECHA guidance (R.8 p. 117), if there are indications of corrosivity, a substance would not be tested for systemic toxicity by any route of exposure. Therefore, testing is not proposed according to Annex IX section 8.6.1 either. See CSR for further information.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- other: 7-day oral dose range-finding
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 01.01.2003 - 30.06.2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Guideline study, final study report not available. Results published in BIOTOX project (BIOTOX. 2005. An assessment of bio-oil toxicity for safe handling and transportation. Final Technical Report. Part I: Publishable Final Report. Report drafted by Blin, J. Project N°: S07.16365. Project co-ordinator: Centre de Coopération Internationale de Recherche Agronomique pour le Développement (Cirad). Partners: Aston University, Bundesforschungsanstalt für Forst- und Holzwirtschaft (BFH)).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- range finding study for 28-day study
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive No 96/54, B7
- Deviations:
- yes
- Remarks:
- range finding study
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Duration of treatment / exposure:
- 7 days
- Frequency of treatment:
- Daily for 7 days
- Remarks:
- Doses / Concentrations:
Basis:
no data - No. of animals per sex per dose:
- 3
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- Clinical signs and mortality were checked daily. Body weight was recorded three times and food consumption twice during the dosing period.
- Sacrifice and pathology:
- On completion of the treatment period, after at least 14 hours fasting, all animals were sacrified by carbon dioxide inhalation and exsanguination. The adrenals, brain, heart, testes and epididymes, kidneys, liver, lungs, ovaries, spleen and thymus were weighed wet.
- Other examinations:
- A complete macroscopic post-mortem examination (external surfaces, all orifices, the cranial cavity, the external surfaces of brain, the thoracic, abdominal and pelvic cavities with associated organs and tissues, neck with associated organs and tissues) was performed on all study animals.
- Statistics:
- The specific sequence was used for the statistical analyses of body weight, food consumption and organ weight data.
- Details on results:
- No macroscopic abnormalities were observed.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: At 150 mg/kg/day, there were no clinical signs of toxicity, a slight and temporary reduction in the body weight gain of the females and no effect on food consumption.
- Key result
- Dose descriptor:
- dose level:
- Effect level:
- >= 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: At 500 mg/kg/day, there were no clinical signs, but there was a reduction in body weight gain and for males, a reduction in food consumption. One male had dilatation of the duodenum.
- Key result
- Dose descriptor:
- dose level:
- Effect level:
- >= 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Key result
- Critical effects observed:
- not specified
- Conclusions:
- Oral NOAEL was determined as 150 mg/kg/day.
- Executive summary:
The potential toxicity of the test item was evaluated following daily oral administration (gavage) to rats for 7 days. The study was conducted according to OECD 407 guideline and was a dose range-finding study for 28 -day study. No hematological, clinical chemistry or histopathology examinations were carried out. According to study results, NOAEL is 150 mg/kg/day.
- Endpoint:
- short-term repeated dose toxicity: oral
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The methodology and results from the study have been published in final technical report of BIOTOX project. (BIOTOX. 2005. An assessment of bio-oil toxicity for safe handling and transportation. Final Technical Report. Part I: Publishable Final Report. Report drafted by Blin, J. Project N°: S07.16365. Project co-ordinator: Centre de Coopération Internationale de Recherche Agronomique pour le Développement (Cirad). Partners: Aston University, Bundesforschungsanstalt für Forst- und Holzwirtschaft (BFH)). The study was a 7-day range finding study. The original final study report is not available.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of repeated dose toxicity via oral route
- systemic effects endpoint:
The only available study for repeated dose toxicity is a 7-day dose
range-finding study conducted for fast pyrolysis bio-oil in BIOTOX
project.
Repeated dose toxicity: via oral route - systemic effects (target
organ) digestive: other
Justification for classification or non-classification
Fast Pyrolysis Bio-oil is not classified for repeated dose toxicity. The data is inconclusive for classification. Fast Pyrolysis Bio-oil may cause toxicological effects following repeated exposure. Those effects are considered to reflect rather corrosivity of the substance than repeated exposure toxicity.
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